Emulsion

ABSTRACT

The invention relates to an orally administrable chewable composition in unit dosage form comprising an oil-in-water emulsion in which the aqueous phase is gelled and in which the oil phase comprises a physiologically tolerable unsaturated fatty acid ester.

FIELD OF THE INVENTION

This invention relates to compositions for oral administration in theform of chewable emulsions containing physiologically tolerableunsaturated fatty acid ester oils.

BACKGROUND OF THE INVENTION

The term unsaturated fatty acid ester oil is used herein to relate toacyl glycerides and phospholipids, i.e. compounds comprising anunsaturated fatty acid side chain linked by an ester group to an“alcohol” (e.g. polyol) residue. Such compounds are important dietarysources of fatty acids, in particular polyunsaturated fatty acids(PUFAs) and more especially the essential fatty acids. They may alsoserve as sources for dietary replacements of essential fatty acids, e.g.of conjugated linoleic acid (CLA) which may be used in a weightreduction diet. Particularly important essential fatty acids include theω-3, ω-6 and ω-9 acids such as eicosapentaenoic acid (EPA) anddocosahexaenoic acid (DHA). Other fatty acids commonly used innutraceuticals and pharmaceuticals include arachidonic acid (AA), alphalinolenic acid (ALA), conjugated linolenic acid (CLN), dihomo-gammalinolenic acid (DGLA) and gamma linolenic acid (GLA). Such fatty acidstypically will contain 12 to 26 carbons, more typically 16 to 22carbons, and will have a saturated or mono- orpoly-ethylenically-unsaturated hydrocarbyl chain.

Typical dietary sources of such fatty acid ester oils include lipidssuch as animal, fish, plant or microorganism triglycerides andphospholipids, especially the triglycerides. Mono or diglycerideshowever can equally be used as can other esters, e.g. lower alkyl (e.g.C₁₋₆ alkyl, for example ethyl) esters as well as free fatty acids orphysiologically acceptable salts thereof and fatty acid ester waxes.Particularly important sources are fish oils, in particular oily fishoils such as cod-liver oil, halibut-liver oil, etc. as these are rich inω-3, ω-6 and ω-9 fatty acids.

However, as anyone who, in childhood, has been on the receiving end offish oils will recall, the taste, mouthfeel and smell can be vile. Inpart this is due to the sensitivity to oxidation of the fish oil. As aresult fatty acid ester oils tend to be administered in capsule form,containing liquid oil within a soft gel casing. Such capsule casings areusually made from mammalian gelatin, typically of porcine or bovineorigin. In order to deliver a reasonable dose of the oil, the capsulestend to be rather large, sufficiently large indeed to cause problemsswallowing them for the young and the elderly. As a result, ingestionoften involves the capsule being chewed and bursting in the mouthreleasing the unpleasantly tasting oil contents.

There is thus a continuing need for improved oral administration formsfor unsaturated fatty acid ester oils.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

We have now surprisingly found that chewable set emulsions ofunsaturated fatty acid esters remain sufficiently free of bad odour andtaste.

Thus viewed from one aspect the invention provides an orallyadministrable chewable composition in unit dosage form comprising anoil-in-water emulsion in which the aqueous phase is gelled and in whichthe oil phase comprises a physiologically tolerable unsaturated fattyacid ester.

The term “chewable” is used herein in its conventional meaning withinthe pharmaceutical and nutraceutical industry. That is the compositionis in a form which can be broken or fragmented by chewing.

The chewable compositions of the invention may be pharmaceuticals, butpreferably are nutraceuticals.

The oil phase of the emulsion will typically comprise a physiologicallytolerable unsaturated fatty acid ester oil as described above,especially an acyl glyceride or a fatty acid ethyl ester, and inparticular a fish or plant triglyceride. More preferably, it contains afish oil. Besides such oils, or mixtures thereof, the oil phase may alsoif desired contain physiologically tolerable lipid soluble materials,e.g. vitamins, antioxidants, flavourings, colours and otherphysiologically active materials. If desired, the oil phase may beconstituted in whole or part by a phospholipid, in particular a marine(eg pelagic fish or shellfish, for example krill) phospholipid. The oilphase preferably contains 25 to 100% of the recommended daily dosage forone or more essential fatty acids, especially EPA and/or DHA. Typicallythe oil phase will constitute 0.05 to 5 g, preferably 0.1 to 3 g,especially 0.2 to 2 g, particularly 0.3 to 1.25 g, more particularly 0.4to 0.75 g, per dose unit. Alternatively put, the oil phase preferablyconstitutes 5 to 75% wt., especially 30 to 50% wt., eg 40 to 50% wt. ofthe dose unit.

The aqueous phase of the emulsion comprises water and a physiologicallytolerable gelling agent, preferably a saccharide (e.g. anoligosaccharide or polysaccharide), a protein or a glycoprotein.Suitable gelling agents are well known in the food, pharmaceutical andnutraceutical industries and several are described for example inPhillips et al. (Ed.) “Handbook of hydrocolloids”, Woodhead Publishing,Cambridge, UK, 2000. The gelling agents are preferably materials capableof undergoing a sol-gel transformation, e.g. under the influence of achange in physiochemical parameters such as temperature, pH, presence ofmetal ions (e.g. group 1 or 2 metal ions), etc.

Preferred for use as the gelling agent is gelatin or a mixture ofgelatin and a polysaccharide, or gellan, or an alginate (eg sodiumalginate), or a mixture of an alginate and glucono-delta-lactone (GDL).The use of fish gelatins is especially preferred.

The gelatins used as gelling agents in the composition of the inventionmay be produced from the collagen of any mammal or the collagen of anyaquatic species, however the use of gelatin from salt-water fish and inparticular cold water fish is preferred. Gelatins having an imino acidcontent of 5 to 25% wt. are preferred, more especially those having animino acid content of 10 to 25% wt. The gelatins will typically have aweight average molecular weight in the range 10 to 250 kDa, preferably75 to 220 kDa, especially 80 to 200 kDa. Gelatins having Bloom values of60-300, especially 90-200 are preferred. The gelatin will typically bepresent in the aqueous phase at a concentration of 1 to 50% wt.,preferably 2 to 35% wt., particularly 5 to 25% wt. In the case ofmixtures of gelatin and polysaccharides, the weight ratio of gelatin topolysaccharide in the aqueous phase will typically be 50:1 to 5:1,preferably 40:1 to 9:1, especially 20:1 to 10:1.

Where polysaccharides, or mixtures of polysaccharides and gelatin areused as the gelling agent, it is preferred to use naturalpolysaccharides, synthetic polysaccharides or semisyntheticpolysaccharides, e.g. polysaccharides from plants, fish, terrestrialmammals, algae, bacteria and derivatives and fragmentation productsthereof. Typical marine polysaccharides include carageenans, alginates,agars and chitosans. Typical plant polysaccharides include pectins.Typical microorganism polysaccharides include gellans and scleroglucans.The use of charged, e.g. electrostatically charged and/or sulphatedpolysaccharides is preferred, as is the use of marine polysaccharides,in particular carageenans, and alginates, especially carageenans.Carageenans are used below as representative polysaccharide gellingagents.

The carageenan family, which includes iota- and kappa-carageenans, is afamily of linear sulphated polysaccharides produced from red algae. Therepeating disaccharide unit in kappa-carrageenan isβ-D-galactose-4-sulphate and 3,6-anhydro-α-D-galactose, while that iniota-carrageenan is β-D-galactose-4-sulphate and3,6-anhydro-α-D-galactose-2-sulphate. Both kappa- and iota-carrageenansare used in food preparations. The carrageenans are used as stabilisers,emulsifiers, gelling agents and fat replacers.

Both iota and kappa carrageenans form salt- or cold-setting reversiblegels in an aqueous environment. Coil-helix transition and aggregation ofhelices form the gel network. Kappa-carrageenan has binding sites forspecific monovalent cations, resulting in gel formation with decreasingshear and elastic moduli in the order Cs⁺>K⁺

Na⁺>Li⁺. As a rule, an increasing salt concentration enhances theelastic modulus and the setting and melting temperatures of akappa-carrageenan gel. The use of water-soluble potassium, rubidium, orcesium compounds, particularly potassium compounds, and particularlynaturally occurring compounds (e.g. salts) is preferred whenkappa-carrageenan is used according to the invention, e.g. atconcentrations of up to 100 mM, more especially up to 50 mM. Asalt-dependent conformational transition is also found foriota-carrageenan. The molecules are also known to undergo coil-helixtransition with strong helix-stabilisation in the presence ofmultivalent cations, like Ca²⁺. The use of water-soluble calcium,strontium, barium, iron or aluminium compounds, especially calciumcompounds, and particularly naturally occurring compounds (e.g. salts)is preferred when iota-carrageenan is used according to the invention,e.g. at concentrations of up to 100 mM.

The polysaccharide gelling agents used according to the invention willtypically have weight average molecular weights of 5 kDa to 2 MDa,preferably 10 kDa to 1 MDa, most preferably 100 kDa to 900 kDa,particularly 400 to 800 kDa. They will typically be used atconcentrations of 0.01 to 5% wt, preferably 0.1 to 1.5% wt.,particularly 0.2 to 1% wt in the aqueous phase. Where mono ormultivalent cations, typically group 1 or group 2 metal ions, areincluded in the aqueous phase, this will typically be at concentrationsin the range 2.5 to 100 mM, particularly 5 to 50 mM.

Besides the gelling agent and water and any required gelling initiator,other physiologically tolerable materials may be present in the aqueousphase, e.g. emulsifiers, emulsion stabilizers, pH modifiers, viscositymodifiers, sweeteners, fillers, vitamins (e.g. vitamin C, thiamine,riboflavin, niacin, vitamin B6, vitamin B12, folacin, panthotenic acid),minerals, aromas, flavours, colours, physiologically active agents, etc.It is especially preferred that a lipophilic antioxidant, e.g. vitaminE, be included in the oil phase. Other vitamins which may be present inthe oil phase are vitamin A, vitamin D and vitamin K Such furthercomponents are used widely in the food, pharmaceutical and nutraceuticalindustries. The use of cellulose derivatives (e.g. hydroxy methyl propylcellulose) as emulsion stabilizers is especially preferred.

The pH of the aqueous phase of the emulsion is preferably in the range 2to 9, particularly 3 to 7.5.

The aqueous phase preferably has a gelling temperature in the range 10to 30° C., more preferably 15 to 28° C., and a melting temperature inthe range 20 to 80° C., more preferably 24 to 60° C., especially 28 to50° C.

Where a sweetener is included in the aqueous phase, this will typicallybe selected from natural sweeteners such as sucrose, fructose, glucose,reduced glucose, maltose, xylitol, maltitol, sorbitol, mannitol,lactitol, isomalt, erythritol, polyglycitol, polyglucitol and glyceroland artificial sweeteners such as aspartame, acesulfame-K, neotame,saccharine, sucralose. The use of non-cariogenic sweeteners ispreferred.

The emulsion preferably has an oil content of 1 to 90% wt, especially 5to 80% wt, more especially 20 to 75% wt. However after emulsificationand gelation the emulsion may be dried to reduce the water content, e.g.to 0.01 to 50% wt, preferably 0.1 to 40% wt, especially 0.5 to 30% wt.Particularly preferably however the aqueous phase, even after any dryingstep, will constitute at least 10% wt., more preferably at least 20%wt., especially at least 30% wt., particularly at least 40% wt. of theemulsion “residue”. Where the emulsion is dried, e.g. by lyophilization,the discontinuous nature of the oil phase is maintained even though thewater content of the emulsion residue may be extremely low. In general,however, where a dried gelled emulsion is used, it is preferred that itstill contains a continuous gel network phase, e.g. as detectable byelectron microscopy.

Examples of physiologically active agents that may be included in thecapsules of the invention include for example analgesics (eg paracetamoland acetyl salicylic acid) and antihistamines

Preferably the overall dose unit weight will be 0.25 to 3 g, especially0.5 to 2.5 g, more especially 0.75 to 2 g.

Viewed from a further aspect the invention provides a method oftreatment of a human by oral administration of an effective amount of anactive agent in oil form or dissolved in an oil, the improvementcomprising administering said active agent in a chewable emulsionaccording to the invention. The method may thus typically be a method oftreatment of a disease or ailment (eg pain), a method of nutritionalsupplementation (eg with a triglyceride) or a method of reducing weight.

Emulsion formation may be effected by conventional techniques; howeveremulsification under a non-oxidising gas, eg nitrogen, is preferred.Likewise, the components of the emulsion are preferably degassed beforeemulsification and handling and packaging of the set emulsion ispreferably performed under such a gas.

The dose units of the emulsion may be formed for example by moulding,extrusion or cutting or the like. For adult use, the dose units arepreferably in tablet or lozenge form; however for child use they mayconveniently be presented in child-friendly form, eg geometric shapessuch as rods, strips and tubes, or animal, doll, or vehicle shapes, forexample the shape of a popular cartoon character.

It is particularly preferred that the compositions according to theinvention contain a citrus flavour (e.g. orange or lemon oil) in orderto mask any remaining oil taste on chewing. It is also particularlypreferred that the compositions according to the invention containxylitol, e.g. as 0.5 to 50% wt., preferably 1 to 40% wt., eg 15 to 40%wt., in order to mask both taste and mouth feel. These may be in theaqueous phase or the oil phase (e.g. as a water-in-oil-in wateremulsion), or both; however inclusion in the aqueous phase willgenerally be sufficient.

The dose units of the compositions of the invention are preferablyindividually packaged in air-tight containers, eg a sealed wrapper ormore preferably a blister of a blister pack. Viewed from a furtheraspect the invention provides a package comprising an air-tightcompartment containing one dose unit of a composition according to theinvention.

The packages according to the invention are preferably in the form ofblister packs containing at least two dose units, eg 2 to 100,preferably 6 to 30. A blister pack, as is well known, usually comprisesa plastic sheet base having moulded indentations or trays in which theitem to be packed is placed. The pack is normally sealed with a foil,generally metal or a metal/plastic laminate, generally by heating theareas between the indentations or trays.

The packages according to the invention are preferably filled under anon-oxidising gas atmosphere (eg nitrogen) or are flushed with such agas before sealing.

Of course, in place of unsaturated fatty acid esters, saturated fattyacids and their esters could also be used and this forms a furtheraspect of the invention.

The invention will now be described further with reference to thefollowing non-limiting Examples.

Example 1 Chewable Emulsion Aqueous Phase

Gelatin: 10% wt.

Sorbitol: 50% wt.

Lemon flavour: 0.15% wt.

Yellow color: 0.1% wt.

Water: 100% wt.

The gelatin is added to the water and allowed to swell for 30 min. Thegelatin solution is then heated to 60° C. under continuous stirring for45 min. The sorbitol is then added to the solution and allowed todissolve under stirring for 30-60 min. The flavour and color are thenadded while stirring. The solution is mixed for 30 min before stirringis stopped and the solution is left for 30 min. The resultant solutionis degassed under vacuum to remove air bubbles. 0.02% wt. lecithin isadded to this solution.

Marine oil (e.g. commercially available fish liver oil) is mixed with0.15% wt. lemon flavour.

The marine oil and the aqueous solution are emulsified in a weight ratioof 1:2 at 45-50° C. using an ultra turrax. When the emulsion is smooth,soft cores are produced by moulding and left to gel for 30 min at 22° C.The cores are dried to reduce the content of water to approximately 15%wt.

Example 2 Chewable Emulsion Shapes

The emulsion is prepared as in Example 1 and filled into an animal shapemould using a syringe. The shapes are then sealed into a blister pack.

Example 3 Chewable Emulsion Aqueous Phase

Gelatin: 10% wt.

Xylitol: 36% wt

Sorbitol: 14% wt.

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

50% citric acid: 1% wt

Water: to 100% wt.

The gelatin is added to the water and allowed to swell for 30 min. Thegelatin solution is then heated to 60° C. under continuous stirring for45 min. The xylitol and sorbitol is then added to the solution andallowed to dissolve under stirring for 30-60 min. The acid, flavour andcolour are then added while stirring. The solution is mixed for 30 minbefore stirring is stopped and the solution is left for 30 min. Theresultant solution is degassed under vacuum to remove air bubbles.

Marine oil (e.g. commercially available fish liver oil) is mixed with0.15% wt. lemon flavour.

The marine oil and the aqueous solution are emulsified in a weight ratioof 1:2 at 45-50° C. using an ultra turrax. When the emulsion is smooth,soft cores are produced by moulding and left to gel for 60 min at 22° C.The cores are dried to reduce the content of water to approximately 10%wt

Example 4 Chewable Emulsion Aqueous Phase

Gelatin: 10% wt.

Xylitol: 36% wt

Sorbitol: 14% wt.

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

50% citric acid: 1% wt

Water: to 100% wt.

The gelatin is added to the water and allowed to swell for 30 min. Thegelatin solution is then heated to 60° C. under continuous stirring for45 min. The xylitol and sorbitol is then added to the solution andallowed to dissolve under stirring for 30-60 min. The acid, flavour andcolour are then added while stirring. The solution is mixed for 30 minbefore stirring is stopped and the solution is left for 30 min. Theresultant solution is degassed under vacuum to remove air bubbles.

Olive oil (e.g. commercially available Ybarra oil) is mixed with 0.15%wt. lemon flavour.

The oil and the aqueous solution are emulsified in a weight ratio of 1:2at 45-50° C. using an ultra turrax. When the emulsion is smooth, softcores are produced by moulding and left to gel for 60 min at 22° C. Thecores are dried to reduce the content of water to approximately 10% wt.

Example 5 Chewable Emulsion Aqueous Phase

Gelatin: 10% wt.

Xylitol: 36% wt

Sorbitol: 14% wt.

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

50% citric acid: 1% wt

Water: to 100% wt.

The gelatin is added to the water and allowed to swell for 30 min. Thegelatin solution is then heated to 60° C. under continuous stirring for45 min. The xylitol and sorbitol is then added to the solution andallowed to dissolve under stirring for 30-60 min. The acid, flavour andcolour are then added while stirring. The solution is mixed for 30 minbefore stirring is stopped and the solution is left for 30 min. Theresultant solution is degassed under vacuum to remove air bubbles.

Rapeseed oil (Landlord REMA 1000) is mixed with 0.15% wt. lemon flavour.

The oil and the aqueous solution are emulsified in a weight ratio of 1:2at 45-50° C. using an ultra turrax. When the emulsion is smooth, softcores are produced by moulding and left to gel for 60 min at 22° C. Thecores are dried to reduce the content of water to approximately 10% wt.

Example 6 Chewable Emulsion Aqueous Phase

Fish gelatin: 10% wt.

Kappa-carrageenan: 0.5% wt

Xylitol: 36% wt

Sorbitol: 14% wt.

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

Water: to 100% wt.

The kappa-carrageenan and fish gelatin is added to the water and allowedto swell for 30 min. The mixture is then heated to 90° C. undercontinuous stirring for 45 min. The xylitol and sorbitol is then addedto the solution and allowed to dissolve under stirring for 30-60 min at70° C. The flavour and colour are then added while stirring. Thesolution is mixed for 30 min before stirring is stopped and the solutionis left for 30 min. The resultant solution is degassed under vacuum toremove air bubbles.

Marine oil (e.g. commercially available fish liver oil) is mixed with0.15% wt. lemon flavour.

The marine oil and the aqueous solution are emulsified in a weight ratioof 1:2 at 45-50° C. using an ultra turrax. When the emulsion is smooth,soft cores are produced by moulding and left to gel for 12 hours at 4°C. The cores are dried at room temperature to reduce the content ofwater to approximately 10% wt

Example 7 Chewable Emulsion Aqueous Phase

Gellan: 0.5% wt

Xylitol: 36% wt

Sorbitol: 14% wt.

Water: to 100% wt.

CaCl₂-solution: 15 mM in the water phase

The gellan is added to the water and the mixture is then heated to 95°C. under continuous stirring for 30 mM. The xylitol and sorbitol is thenadded to the solution and allowed to dissolve under stirring for 30-60mM at 70° C. The solution is mixed for 30 mM before stirring is stoppedand the solution is left for 30 mM. The resultant solution is degassedunder vacuum to remove air bubbles.

Marine oil (e.g. commercially available fish liver oil) is mixed with0.15% wt. lemon flavour.

The marine oil and the aqueous solution are emulsified in a weight ratioof 1:2 at 60° C. using an ultra turrax. When the emulsion is smoothCaCl₂ is added to a final concentration of 15 mM and soft cores areproduced by moulding and left to gel for 180 mM at 4° C. The cores aredried at room temperature to reduce the content of water toapproximately 10% wt.

Example 8 Chewable Emulsion Aqueous Phase

Gelatin: 7.5%

Xylitol: 36% wt

Sorbitol: 14% wt.

50% citric acid: 1% wt

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

Water: to 100% wt.

Paracetamol: 125 mg/1.5 g emulsion

The gelatin is added to the water and allowed to swell for 30 min. Thegelatin solution is then heated to 60° C. under continuous stirring for45 min. The acid, xylitol and sorbitol is then added to the solution andallowed to dissolve under stirring for 30-60 min. The flavour and colourare then added while stirring. The solution is mixed for 30 min beforestirring is stopped and the solution is left for 30 min. The resultantsolution is degassed under vacuum to remove air bubbles.

Olive oil is mixed with 0.15% wt. lemon flavour.

The olive oil and the aqueous solution are emulsified in a weight ratioof 1:2 at 60° C. using an ultra turrax. When the emulsion is smoothparacetamol powder is mixed into the emulsion with a ultra turrax andsoft cores are produced by moulding and left to gel for 180 min at 20°C. The cores are dried at room temperature to reduce the content ofwater to approximately 10% wt.

Example 9 Chewable Emulsion Aqueous Phase

Na-alginate: 0.5% wt

Xylitol: 36% wt

Sorbitol: 14% wt.

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

Water: to 100% wt.

GDL: 30 mM

CaCO₃: 15 mM

The alginate is added to the water and dissolved under continuousstirring at room temperature for 6 hours. The xylitol and sorbitol isthen added to the solution and allowed to dissolve under stirring for30-60 mM at 70° C. The solution is cooled to room temperature andflavour and colour is added. The resultant solution is degassed undervacuum to remove air bubbles.

Marine oil (e.g. commercially available fish liver oil) is mixed with0.15% wt. lemon flavour.

The marine oil and the aqueous solution are emulsified in a weight ratioof 1:2 at room temperature using an ultra turrax. When the emulsion issmooth the CaCO₃ and GDL powders are added (one by one) and mixed intothe emulsion by the ultra turrax. Soft cores are produced by mouldingand left to gel for 24 hours at room temperature. The cores are dried atroom temperature to reduce the content of water to approximately 10% wt

Example 10 Chewable Emulsion Aqueous Phase

Na-alginate: 0.5% wt

Xylitol: 36% wt

Sorbitol: 14% wt.

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

Water: to 100% wt.

Calsiumsulphate (CaSO₄×2H₂O): 0.3%

Tetrasodiumpyrophosphate (Na₄P₂O₇): 0.03%

The alginate is added to the water and dissolved under continuousstirring at room temperature for 6 hours. The xylitol and sorbitol isthen added to the solution and allowed to dissolve under stirring for30-60 min at 70° C. The solution is cooled to room temperature andflavour and colour is added. The resultant solution is degassed undervacuum to remove air bubbles.

Marine oil (e.g. commercially available fish liver oil) is mixed with0.15% wt. lemon flavour.

The marine oil and the aqueous solution are emulsified in a weight ratioof 1:2 at room temperature using an ultra turrax. When the emulsion issmooth the CaSO₄ and tetrasodiumpyrophosphate powders are added (one byone) and mixed into the emulsion by the ultra turrax. Soft cores areproduced by moulding and left to gel for 24 hours at room temperature.The cores are dried at room temperature to reduce the content of waterto approximately 10% wt.

Example 11 Chewable Emulsion Aqueous Phase

Gelatin: 10% wt.

Xylitol: 36% wt

Sorbitol: 14% wt.

Lemon flavour: 0.15% wt.

Yellow colour: 0.1% wt.

50% citric acid: 1% wt

Water: to 100% wt.

Vitamin C (ascorbic acid): 10 g

The gelatin is added to the water and allowed to swell for 30 min. Thegelatin solution is then heated to 70° C. under continuous stirring for45 min. The xylitol and sorbitol is then added to the solution andallowed to dissolve under stirring for 30-60 min. The acid, flavour andcolour are then added while stirring. The temperature is lowered to 50°C. and the vitamin C powder is added to the solution. The solution ismixed for 30 min before stirring is stopped and the solution is left for30 min.

Marine oil (e.g. commercially available fish liver oil) is mixed with0.15% wt. lemon flavour.

The marine oil and the aqueous solution are emulsified in a weight ratioof 1:2 at 40-45° C. using an ultra turrax. The resultant emulsion isdegassed under vacuum to remove air bubbles. When the emulsion issmooth, soft cores are produced by moulding and left to gel for 60 minat 22° C. The cores are dried to reduce the content of water toapproximately 10% wt.

Example 12 Blister Packs

The emulsion cores of Examples 1, 2 and 4 to 11 are filled into plasticblister pack trays over which a plastic/metal foil laminate is heatsealed.

Example 13 Chewable Strips

Before setting, the emulsions of Examples 1, 2 and 4 to 12 are extrudedinto strips which are then sealed into individual plastic/metal foillaminate envelopes.

What is claimed is:
 1. An orally administrable chewable composition inunit dosage form comprising a chewable, set oil-in-water emulsion inwhich the aqueous phase is gelled and constitutes about 50% to 60% wt.of the unit dosage form, wherein said aqueous phase comprises gelatin inan amount of about 10% to 25% wt. of the aqueous phase and wherein theoil phase comprises a physiologically tolerable omega-3 or omega-6 fattyacid ester and constitutes about 40% of the dose unit, and wherein theunit dosage form has an overall dose unit weight of 0.25 to 3 g, andwherein the composition, upon chewing, remains free of bad odor andtaste.
 2. The composition as claimed in claim 1, wherein the omega-3 oromega-6 fatty acid ester is a physiologically tolerable triglyceride. 3.The composition as claimed in claim 1, wherein the omega-3 or omega-6fatty acid ester is a fish oil.
 4. The composition as claimed in claim1, wherein said aqueous phase further comprises polysaccharides.
 5. Thecomposition as claimed in claim 1, wherein said aqueous phase furthercomprises carageenan.
 6. The composition as claimed in claim 1, furthercomprising at least 1% wt. xylitol.
 7. The composition as claimed inclaim 1, further comprising a citrus flavor.
 8. The composition asclaimed in claim 1, wherein said aqueous phase further comprises a watersoluble vitamin.
 9. The composition as claimed in claim 1 in animal,doll, vehicle, rod, strip or tube shape.
 10. A package comprising anair-tight compartment containing one dose unit of a composition asclaimed in claim
 1. 11. The package as claimed in claim 10 in the formof a blister pack.
 12. A method of treatment of a human by oraladministration of an effective amount of an active agent in oil form ordissolved in an oil comprising administering said active agent in achewable composition according to claim
 1. 13. The method as claimed inclaim 12, wherein said active agent is an analgesic.
 14. The method asclaimed in claim 12, wherein said active agent is a triglyceride.